Clinical Study to Evaluate Effectiveness of Digital Refraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2018-07-06

Brief Summary

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Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.

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Detailed Description

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A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.

LogMAR (ETDRS) chart to measure visual acuity.

The manual manifest refraction is performed by an eyecare specialist using a phoropter.

The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.

Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Digital refraction

Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone

Group Type EXPERIMENTAL

Manual Refraction

Intervention Type OTHER

Manual refraction and ETDRS chart

Manual Refraction

Manual manifest refraction is performed by an eyesore specialist using a phoropter.

Group Type ACTIVE_COMPARATOR

Digital refraction

Intervention Type DEVICE

A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.

Interventions

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Digital refraction

A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.

Intervention Type DEVICE

Manual Refraction

Manual refraction and ETDRS chart

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subject must be between 22 and 55 years of age at the time of consent.
2. Subject must have a refractive error

1. With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye.
2. With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye.

5\. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.

Exclusion Criteria

1. Subjects with diabetes mellitus.
2. Subjects using ophthalmic or systemic corticosteroids.
3. Subjects with autoimmune conditions.
4. Subjects with active corneal or conjunctival infection.
5. Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
6. Subjects with diabetic retinopathy.
7. Subjects with glaucoma or ocular hypertension.
8. Subjects with macular degeneration.
9. Subjects with previous ocular surgery.
10. Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex).
11. Pregnancy
12. Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Minimum Eligible Age

22 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes